vulnerable elderly people in biomediCal researCh: what are the responses in european law?

Abstract

As the main medications consumers, elderly persons are estimated to represent
up to 30% of the European population in 2050. Paradoxically there is a
considerable lack of information about drug prescription in older persons, which
is compromising the quality of treatments, and leaving to physicians the
considerable responsibility of improvised prescriptions, which are potentially
either dangerous or ineffective. In fact, the geriatric population is either excluded
from clinical trials or represented by relatively healthy elderly persons who do
not accurately represent real world patients. Despite repeated demonstrations of
the need to include frail elderly persons in clinical trials in the medical literature,
European law only offers disappointing responses to the problem. The frequent
decline in older persons’ cognitive capacities makes the task even more difficult
(cognitive frailty, early dementia like Alzheimer’s disease or psychiatric
disorders). Many older persons have reduced decision making capacity without
benefiting from legal protection yet. Surprisingly, ethics guidelines as well as
European law are not very sensitive to the phases before legal incompetence, and
do not consider alternative ways to obtain informed consent as suggested in
medical and ethical literature. Although these questions fall under national
competencies, the issue is common to Europe and solutions will necessarily have
to go beyond state borders. Involving the European legislator is essential in order
to at least act as an incentive for a better inclusion of frail elderly persons in
biomedical research, and for a better promotion of their autonomy.